BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Ophthalmic Forceps

    FDA UDI
    KATENA PRODUCTS, INC.·00841668106136·HOSKIN #22 COLIBRI FORCEPS

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575239818·Orthopaedic prosthesis implantation instrument,...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575239801·Orthopaedic prosthesis implantation instrument,...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575239900·Orthopaedic prosthesis implantation instrument,...

    MaxFuse,VBR, 12 (D) x 14 (W) x 17 (H)

    FDA UDI
    Pioneer Surgical Technology, Inc.·00846468055967·12 (D) x 14 (W) x 17 (H)

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575238866·Orthopaedic prosthesis implantation instrument,...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575239825·Orthopaedic prosthesis implantation instrument,...

    LinkSymphoKnee - Instruments

    FDA UDI
    WALDEMAR LINK GmbH & Co. KG·04026575239894·Orthopaedic prosthesis implantation instrument,...

    ALYTE Y-MESH GRAFT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TRICOS T

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONTOUR® NEXT

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

    IDENTITY ADX XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC CRMD·Product code DXY·January 13, 2014

    SWEET TIP

    FDA Adverse Event
    Injury ·HISTORICAL PUERTO RICO·Product code NVN·July 6, 2011

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Malfunction ·RICE CREEK MFG·Product code OJX·June 7, 2013

    2.4MM TI VA LOCKING SCREW STARDRIVE 24MM-STERILE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·April 30, 2019

    AERO LL FIXATION ANCHOR, 50MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code OVD·March 25, 2019

    CONTOUR® PLUS

    FDA Adverse Event
    Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

    Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 20, 2013

    BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·BioFire Diagnostics, LLC·August 30, 2023